Research assistant Natalie Thomas pulls a slice of a cancerous tumor for analysis at the Anschutz Medical Campus. (Andy Cross, The Denver Post)

Ellen Smith received a death sentence for her advanced lung cancer five years ago, but it was commuted by a revolution in human genetics, drug therapies and clinical approaches unfolding at the University of Colorado Hospital.

The advances have saved her life, by her reckoning, four times.

The accelerating speed of DNA sequencing, drug development and data analysis has led UCHealth, the University of Colorado Medical School and Children's Hospital Colorado to join in an effort to fundamentally change the way they care for patients.

The partnership will invest more than $63 million over the next five years to create a new division, adding clinicians, genetic counselors, researchers and advanced practice nurses — and also expanding a DNA bank and advanced data warehouse. It's called the Center for Personalized Medicine and Biomedical Informatics.

The pioneering field of personalized medicine uses molecular analysis to determine a patient's predisposition to developing certain diseases and to deliver tailored medical treatment.

"There is no doubt in my mind that this will change how we treat disease, how we teach our students, how physicians work, how we raise our kids and how we conduct public health policy," Dr. David Schwartz, chair of the CU Department of Medicine, said of the center.

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The DNA bank, Schwartz said, probably will require a year of discussion with physicians, academicians, lawyers, ethicists and patient advocates about what it really means to secure patients' genetic blueprints and how they should be used.

While the center will be based on the Anschutz Medical Campus in Aurora, it will serve UCHealth's five hospitals and Children's Hospital. The DNA bank would sequence and analyze samples from around the region.

The benefits of personalized medicine have been evident for several years in cancer treatment, said Dr. Dan Theodorescu, director of the CU Cancer Center. It's why the center's survival rates are significantly better for certain types of cancers than the average national outcomes, he said. The new center will bring these kinds of lifesaving therapies to all disease fronts while providing more laboratory and analytical power to evaluate cancer DNA, he said.

Smith, now 64, a nonsmoking, retired schoolteacher from Centennial, was diagnosed with lung cancer in April 2008. Little more than a year later, and despite having surgery to remove her left lung, her doctor told her the cancer had spread to her abdominal area and right kidney.

"I'm sorry," he told her, "there isn't anything I can do."

She consulted her bucket list and took a trip to Scotland. Before she left, a friend urged her to go to CU's hospital.

Smith gave tissue and blood samples and left the country. During her trip, her cancerous kidney began bleeding, sending her to an emergency room. On the same day, she got a call from CU Hospital.

After sequencing her tumor's DNA, clinicians found she is among the 4 percent of patients whose cancer, caused by a genetic rearrangement, should respond to an experimental drug.

"It was the worst day of my life and the best day of my life," Smith said.

When she got back to Colorado, it was two pills in the morning and two pills in the evening. The side effects were minimal.

She asked her doctor, Ross Camidge, director of Thoracic Oncology Clinical at CU School of Medicine, whether she was part of a study. "He told me: 'Ellen, you are the study.' "

Her cancer stopped growing. The growths soon became so small they could no longer see it on her cancer scans.

The Pfizer drug crizotinib, whose trade name is Xalkori, would become one of the fastest licensed drugs in oncology — tried in 2007 and licensed in 2011, according to Camidge.

A shift occurred in the development of cancer drugs. It was no longer about finding a blockbuster drug that worked for everybody, but about finding the drug that works amazingly well in a few people — "a niche-buster" drug.

"One size does not fit all," Camidge said. "There is no one treatment for cancer."

What has been driving precision, personalized medicine is what is one of the greatest medical explorations in history — the international research effort to sequence and map all human genes. The Human Genome Project, completed in 2003, gave scientists the genetic blueprint for creating a human being and for understanding what can go wrong inside one.

"It took the next eight or nine years for us to understand how it relates to disease, to understand disease in a much more profound way," Schwartz said.

Even a few years ago, sequencing genes was prohibitively expensive, but costs are plummeting, Schwartz said.

Centers for personalized medicine date back at least as early as 2001, when Harvard Medical School established the Harvard-Partners Center for Genetics and Genomics.

While not among the earliest, CU's center will be positioned on the cutting edge because of its research and clinical strengths in a still-developing health care trend, said Amy Miller, vice president of public policy for the Personalized Medicine Coalition.

"We're marrying our academic program and progressive community hospitals," said CU Health interim CEO Dr. William Neff. "We've got some great separate pieces — education, research, clinical — and we're trying to integrate them. It's critical to have a fully integrated electronic record system, and it's a really hard thing to do. It's a technology and culture shift."

CU will scale up, Schwartz said. It will use knowledge gleaned from computer analyses of a vast storehouse of DNA and other medical information to identify disease risk, prevent disease, or find and apply the best treatments at the earliest stages.

Building a DNA bank requires patients' willingness to provide samples for DNA analysis and to participate in genetics studies without fear that information will be misused, Miller said.

Like all medical information, DNA data is protected by federal guidelines on research subjects and by laws protecting patients' privacy. Most recently, the 2008 Genetic Information Nondiscrimination Act established protections for patients' genetic information from misuse by employers or insurers.

Still, it's an evolving field with many ethical issues. Jennifer Miller, president of the Bioethics International Edmond J. Safra Center for Ethics at Harvard University, writes that those issues include equitable access to personalized medicine, respecting patients' rights to decide on their participation, obtaining quality-informed consents, and intellectual and other property rights.

Concerns in patients' minds on privacy and ownership issues are often eclipsed by the promise personalized medicine holds to help heal them, Camidge said.

It turned out that Smith's reprieve from cancer was just that — a lull in the disease that ended in one recurrence and another. It takes just one mutant cancer cell, Smith said, to resist a drug.

Camidge used chemotherapy, radiation and other drugs, along with repeated use of the Xalkori, to save her, she said, three more times and to stretch the reprieve into years.

If Smith's last "four lives" sound to some like an ordeal, and perhaps not worth it, she would disagree.

"The last six years have been a true gift of time," she said. "I know what's important — faith, family and friends. I got married. I've had four more grandchildren. I've traveled."

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